Apparatus for and method of collecting and preserving cytologic samples

ABSTRACT

Apparatus is provided in a kit form for use in collecting cell specimens most generally from the vaginal tract and cervix region of a female person to preserve the specimens for subsequent cytologic study. A cell collecting device has a collecting end of a multi-ridge perimeter formed from sponge-like material with a handle at an opposite end. The cell sample collecting device has a notched shaft for separating the device collecting end from the device handle end in order for the cell collecting end to be separately sealed in a cell preservative solution included as a part of the kit. Additionally or alternatively, slides can be provided for depositing the collected cell sample thereon. A cell preservative fixative is applied over the specimens on the slides. The slides and/or the sealed device collecting end are then mailed or delivered for analysis.

Umte States atent- 1 9 i 1 V, 111 3,815,580 Oster v 1 June 11, 1974 APPARATUS FOR AND METHOD OF J.A.M.A., Nov. 19,' 1955, Vol. 159, N0. 12, pp.

COLLECTING AND PRESERVING 1 177-1178. CYTOLOGIC SAMPLES I [76] Inventor: Claude Oster, 97 6 Stuyvessant, P -E Howe Birmingham Mich 48014 Attorney, Agent, or Firm--Bernard D. Bogdon [22] Filed: Aug. 31, 1972 [21] Appl. No.: 285,204

[ ABSTRACT (1| 123/2' W, 1 103-5 R Apparatus is provided in a kit form for use in collectcell pecimens most generally from the agina] 1 Field of Search 128/2 B, 2 2 269, tract and cervix region of a female person to preserve 128/304; 206/632 R; 195/103.5 R the specimens for subsequent cytologic study. A cell collecting device has a collecting end of a multi-ridge References Cited perimeter formed from sponge-like material with a UNITED STATES PATENTS handle at an opposite end. The cell sample collecting 2,591,927 4/1952 Gladstone 128/2 B a notched Shaft for separatingme device 2,835,246 5/1958" Boettger 128/2 w eolleetmg end from e e e and e e In r e or 2,905,169 9/1959 Nieburgs 128/285 X the cell collecting end to be separately sealed in a cell 2,985,288 5/1961 Reich 195/103.5 R preservative solution included as a part of the kit. Ad- 3,5|3,830 5/1970 Kalayjian 128/2 W or alternatively lides can be provided for 3,540,432 11/1970 Ayre.,. 128/2 B depositing the collected cell sample ml-eon- A Cell 1 5 21; preservative fixative is applied over the specimens on T712296 1 1973 Gradonc ..11111113311. 1:31.: 128/2 w Shdes' The Sealed dev'ce 9 3:724:46 4/1973 Vail 128/269 mg end are mulled dehvered for analysls- OTHER PUBLICATlONS 1 Claim, 9 Drawing Figures Cancer, Vol. 7, November, 1954, pp. 1182-1184.

1. APPARATUS FOR AND METHOD F COLLECTING AND PRESERVING CYTOLOGIC SAMPLES BACKGROUND OF THE INVENTION 1. Field of the Invention This invention relates to medical apparatus and method for collecting and preserving cell specimens for cytologic evaluation and in particular to medical apparatus in kit form for self-administering including the collection of and preservation of cells for subsequent examination.

2. Description of the Prior Art:

In an effort to make medical attention available to a greater percentage of the .worlds population many medical kits designed to be safely administered by individual users are becoming available in the marketplace. These kits can generally be obtained from local outlet stores and carry sufficient instructional information so that they can be safely administered by most people. If individuals properly follow the instructions with the suggested amount of care, very reliable results can be obtained through the use of the medical kits and in specitic in the use of those kits where cells are collected for subsequent examination in the process of detecting and determining cancer. Since the individuals, which include primarily females, can collect these cell samples without difficulty or discomfort but cannot examine the results of their collection because they lack the proper equipment and expertise, it is necessary that the efforts of their collection, the cells, be preserved and forwarded to laboratories or other areas where proper evaluation can be conducted.

Well-known aspirator type devices have appeared on the market as collection devices useful in obtaining cells generally from the area of a womans vagina for laboratory examination. It should be understood that any locally available self-administering cell collecting device cannot substitute for a good thorough examination by a specially qualified doctor.

Devices for use in making self-examination and collection are not particularly new to the public, for example, in US. Pat. No. 2,905,169 issued to H.E. Neiburgs on Sept. 22, 1959 entitled DEVICES FOR CANCER DETECTION there is included disclosure of a device designed to'be useful in cell collection and capable of being self-administered. In Neiburgs there is disclosed a tampon type cell collecting device which after being self-administered, generally in a female, is placed onto a microscope type slide to form a smear, with the tampon and slide remaining intact for subsequent evaluation by qualified examiners. As identified in Neiburgs, a suitable period of time for contact of the tampon with the female at the area where the cell collection is taking place, such as at the cervix, is necessary in order to insure fully reliable examination results. The time period might extend from 4 to 24 hours.

BRIEF DESCRIPTION OF THE DRAWINGS FIG. I is a preservative view of a kit and its contents, embodiments according to the principles of the present invention, for use in self-collection and preservation of sample cells.

FIG. 2 illustrates one embodiment of a sliding cover for the kit illustrated inFlG. 1.

' FIG. 3 illustrates another embodiment of a hinged cover for the kit illustrated in FIG. 1.

FIG. 4 illustrates a plan view of a cell collecting device according to the-principles of the present invention.

FIG. 5 illustrates an end view of the cell collecting portion of the embodiment of FIG. 4.

FIG. 6 illustrates an end view of an alternate configuration of the embodiment illustrated in FIG. 4.

FIG. 7 illustrates a plan view of a cell preservation container as shown in the kit of FIG. 1.

FIG. 8 illustrates a cross-sectional side view of the cell preservation container including the cell collecting portion of the embodiment of FIG. 4.

FIG. 9 illustrates a portion of thekit of FIG. 1 including slides for smearing with cells collected by the cell collecting portion of the embodiment of FIG. 4.

DESCRIPTION OF THE PREFERRED EMBODIMENTS As proponents of ecology and consumers rights and social welfare advance their causes, more and more attention is being directed to measures of aiding a greater percentage of those in need in the world population. Although many medical advances have been steadily made over'the centuries and recent decades in the practice of medicine, more and more people have become aware of the fact that the same rate of improvement is unacceptable if we are to reach those portions of the general public which are not served. Accordingly, a low cost convenient kit 10 of FIG. 1 is provided for self-administering to include cell collecting instructions 12, cell collecting apparatus 14 and cell collecting preservative measures including cell preservation container 16 and/or cell slides 18 and 20.

Since the kit 10 is intended for safe and convenient use, it will be attractively and conveniently packaged in order to insure that the equipment included with it are kept clean and uncontaminated during handling. FIGS.

2 and 3 illustrate sliding cover 22 and hinged cover 24,-

' general cylindrical shape. Preferably, however, as illustrated in FIG. 5, the perimeter of the collecting end 26 is multiedged and is, for example, octagonal. The octagonal shape, as shown in FIG. 5, has equal length sides 28 which intersect to form the ridge edges 30. The extreme end of a nose portion 31 of the-cell collecting end 26 uniformly tapers from each of the respective sides 28 to a flat end surface 32. In an alternative configuration, as illustrated in FIG. 6, the nose portion has uniform taper from each of the sides 28 to an apex point 33 at an extreme point of the collecting end 26.

The sample collecting device is administered to a human body in an extremely convenient and comfortable manner and has a handle end 34 joined to the cell collecting end 26 by a notched shaft 36, as best seen in FIG. 4. The handle end 34 and the notched shaft 36 are formed of any suitable material such as plastic. The

shaft 36, notwithstanding a notch 38, is of sufficient material strength to be especially maneuverable during handling and administration of the cell collecting de- In patentees U.S. Pat. No. 3,592,186 issued July I3. I l 1971 and entitled CYTOLOGIC SCRAPER," there is included sufficient detail and disclosure, which for the most part can be readily adapted to the administration of the presently disclosed I cell collecting device, in order to practice and use the herein disclosed embodiments with relative ease and comfort to gain reliable results. Appropriate simplified directions can be printed upon cell collecting instructions 12 to aid any person in administering the cell collecting device 14 and preserving the collected cells. In the case of illiterate people, simply picture diagrams can be readily used to successfully carry the message of operation and practice to them.

Applicants' cell collecting apparatus 14 is significantly different from the cell collecting devices known to exist. The human engineering aspects, including the totallength and width of cell collecting end 26, are such that the vast majority of females can, without the aid of another person, conveniently, 'easily and comfortably administer and operate the cell collecting apparatus 14 within their respective bodies to collect cell specimens particularly from the vaginal and the cervix regions. It will be appreciated that the cell collecting device 14 as illustrated in FIG. 4 of the present disclosure, can readily be used with the cover 14, as best illustrated in FIG. 2 of applicants issued U.S. Pat. No. 3,592,186. In actual application, the present device could then be easily administered as illustrated and described for FIG. 6 of the previously mentioned applicants patent.

Once collection of the cells has been accomplished it is necesary to preserve the collected samples for subsequent examination by qualified analysts serving at properly equipped analysis stations. According to the principles of applicants invention, preservation can be accomplishedin at least one of two or more different ways. FIGS. 7 and 8 illustrate, in more detail, the cell preservation container 16 of FIG. 1. The cell preservation container 16 comprises a preservative fluid holding body 40 and an interlocking sliding cover 42. The sliding cover 42 is interlocked to the fluid holding body 40 by any suitable means such as by integrally formed sliding rails 44 and 46 disposed at the top and at opposite sides of the fluid holding body 40. Cooperatively engaged with the sliding rails 44 and 46 and formedas an integral part of cover 42, are interlocking guides 48 and 50 disposed at opposite sides of the cover 42. The cover 42 and the fluid holding body 40 when fully engaged, lock in any suitable manner such as a snap lock to make a fluid tight seal to preclude preservative from leaking from the container 16 and to preclude contaminates from entering into the container 16. Immediately after a person collects cells the cell collecting portion 26 of the cell collecting device 14 is inserted into the preservative solution or fluid 51 and the sliding cover 42 is caused to slide in the direction of arrow 52 to engage the notch 38 of the shaft 36 at a shaft breaking assembly 54.

The shaft breaking assembly 54 comprises for example an irregular saw tooth arrangement 56, most proba- I bly integrally formed with the fluid holding body 40 at its uppermost edge and an arcuate shaped cutout 58 formed at the edge of the sliding cover 42. The notch 38, the shaft 36, the saw tooth arrangement 56 and arcuate cutout 58 are designed in such a manner'that only a slight amount of force is necessary to break the shaft 36 at the notch 38. This can be accomplished either by persuading the cover 42 in the direction ofv arrow 52 with the notch 38 at the breaking assembly 54 until the shaft 36 is severed at the notch 38, or by holding the notch 38 at the breaking assembly 54 and bending the shaft 36 at that part of the shaft designated 36'. in the direction of arrow 60 until the shaft 36 is severed at the notch 38.

The cell preservation container 16 including the body 40 and the cover 42 are formed of suitable material to hold and seal the preservative solution 51 and to account for the severing of the shaft 36 at the notch 38. The suitabe material may be one or a combination from the plastic family. The cell preservative solution 51 may be, for example, an alcohol and water mixture or simply a suitable solution similaror identical to commereially available'unscented hairspray.

In the alternative, or as a duplicate step to insure and confirm reliable analysis results, slides 18 and 20-may be smeared with cells collected by the cell collecting device 14 and processed for further examination. As hereinbefore mentioned, slides 18 and 20 are part of kit 10 and more specifically are included in self-contained slide holder box 62. As will be appreciated from the disclosure in patentees hereinbefore mentioned U.S. Pat. No. 3,592,186, a suitable cell collecting device such as device 14 must collect cells from all portions to be investigated. In the case of a woman selfadministering the cell collecting device 14 in the area of her vagina and cervix, it is necessary to insure that cells be collected from all portions of the area under investigation, in order to provide reliable analysis results. From FIGS. 4, 5 and 6, it will be appreciated that, for example, the cell collecting end 26 might best, at its sides 28 and ridge edges 30, collect cells from the vaginal region and might best, at its nose portion 31 at either the flat end surface 32 or the apex point 33, collect cells from the cervix region. Accordingly, as best shown in FIG. 9, the cell collecting device 14 isin one instance rolled along slide 20, in a motion in the direction of arrow 64, to deposit upon the slide, cells which have adhered to sides 28 and the ridge edges 30 of the cell collecting end .26. In another instance, the cell collecting end 26 is dragged along slide 18, in the direction of arrow 66, to deposit upon the slide, cells which have adhered either to the flatend surface 32 or the apex 33 of the cells collecting end 26. Fixatives are then applied over each of the slides 18 and 20 to properly preserve and adhere the cells to the slides for subsequent examination. The slide holder box 62 may then be either covered, for example, in either manner as hereinbefore described for FIGS. 2 and 3 with regard to the kit 10 and delivered or mailed to the respective appropriate station for cytologic examination and analysis.

I claim l. A cytologic collection and preservation system for preserving collected cell specimens in a preservative liquid, comprising the combination of a cytologic collecting device enclosed within an elongated closed container containing cell preservative liquid wherein the collecting device has a collector end for collecting cell specimens with a cylindrical shaft extending from the collector end to a notched shaft portion disposed at an end of the collecting device opposite the collector end, said collector end having a collector body and a collector nose collectively including sponge'like material disposed substantially symmetrically about the cylindrical shaft wherein the collector body has a multi-ridge perimeter with a first set of ridges longitudinally orientated and parallel to the shaft and wherein the collector nose has a second set of ridges extending from the multi-ridge perimeter of the collector body and converging toward a point at the end of the collecting device opposite the notched shaft portion to dispose both the collector body and the collector nose for collecting cell specimens and wherein the elongated container enclosing the collecting device has a closed bottom for holding the cell preservative liquid and an open top for initial insertion of the collecting device into the container with a shaft bearing area integral with and disposed at I the top of the container and further including a con tainer cap slidably engaged at the top of the container for closing the container and sealing the liquid within the container, said cap having an arcuately shaped cutout at one edge of the cap for engaging and aligning the notched shaft portion of the collecting device with the shaft bearing area disposed at the top of the container wherein when the collecting device is initially inserted into the container the cap, slidably engaged with the container, causes the notched shaft portion of the collecting device to bear against the cap cut-out at one edge of the cap and the bearing area at the top of the container to break the shaft of the collecting device at the notched shaft portion and separate it from a handle of the collecting device to thereby seal the collecting device within the container in the preservative liquid for preserving the cell specimens collected by the collector body and collector nose of the collecting device. 

1. A cytologic collection and preservation system for preserving collected cell specimens in a preservative liquid, comprising the combination of a cytologic collecting device enclosed within an elongated closed container containing cell preservative liquid wherein the collecting device has a collector end for collecting cell specimens with a cylindrical shaft extending from the collector end to a notched shaft portion disposed at an end of the collecting device opposite the collector end, said collector end having a collector body and a collector nose collectively including sponge-like material disposed substantially symmetrically about the cylindrical shaft wherein the collector body has a multi-ridge perimeter with a first set of ridges longitudinally orientated and parallel to the shaft and wherein the collector nose has a second set of ridges extending from the multi-ridge perimeter of the collector body and converging toward a point at the end of the collecting device opposite the notched shaft portion to dispose both the collector body and the collector nose for collecting cell specimens and wherein the elongated container enclosing the collecting device has a closed bottom for holding the cell preservative liquid and an open top for initial insertion of the collecting device into the container with a shaft bearing area integral with and disposed at the top of the container and further including a container cap slidably engaged at the top of the container for closing the container and sealing the liquid within the container, said cap having an arcuately shaped cut-out at one edge of the cap for engaging and aligning the notched shaft portion of the collecting device with the shaft bearing area disposed at the top of the container wherein when the collecting device is initially inserted into the container the cap, slidably engaged with the container, causes the notched shaft portion of the collecting device to bear against the cap cut-out at one edge of the cap and the bearing area at the top of the container to break the shaft of the collecting device at the notched shaft portion and separate it from a handle of the collecting device to thereby seal the collecting device within the container in the preservative liquid for preserving the cell specimens collected by the collector body and collector nose of the collecting device. 